GE HealthCare Technologies Inc. Tops FDA List with 100 AI-Enabled Medical Device Authorizations for Fourth Consecutive Year

Reuters07-23

GE HealthCare Technologies Inc. Tops FDA List with 100 AI-Enabled Medical Device Authorizations for Fourth Consecutive Year

GE HealthCare Technologies Inc. has achieved a significant milestone by securing its 100th authorization for AI-enabled medical devices from the U.S. Food and Drug Administration (FDA). This marks the fourth consecutive year that GE HealthCare has topped the FDA's list of AI authorizations, underscoring its leadership and innovation in the field. The authorizations, obtained through various FDA pathways such as 510(k) clearances, De Novo requests, or premarket approvals, reflect GE HealthCare's commitment to advancing precision care across imaging modalities and care pathways, including oncology, cardiology, and neurology. This achievement highlights the company's ongoing investment in research and development, as well as its dedication to leveraging AI, cloud, and software to enhance patient outcomes and healthcare efficiency.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. GE HealthCare Technologies Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250723673565) on July 23, 2025, and is solely responsible for the information contained therein.

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Tops FDA List with 100 AI-Enabled Medical Device Authorizations for Fourth Consecutive Year\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        GE HealthCare Technologies Inc. has achieved a significant milestone by securing its 100th authorization for AI-enabled medical devices from the U.S. Food and Drug Administration (FDA). This marks the fourth consecutive year that GE HealthCare has topped the FDA's list of AI authorizations, underscoring its leadership and innovation in the field. The authorizations, obtained through various FDA pathways such as 510(k) clearances, De Novo requests, or premarket approvals, reflect GE HealthCare's commitment to advancing precision care across imaging modalities and care pathways, including oncology, cardiology, and neurology. 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Tops FDA List with 100 AI-Enabled Medical Device Authorizations for Fourth Consecutive Year\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        GE HealthCare Technologies Inc. has achieved a significant milestone by securing its 100th authorization for AI-enabled medical devices from the U.S. Food and Drug Administration (FDA). This marks the fourth consecutive year that GE HealthCare has topped the FDA's list of AI authorizations, underscoring its leadership and innovation in the field. The authorizations, obtained through various FDA pathways such as 510(k) clearances, De Novo requests, or premarket approvals, reflect GE HealthCare's commitment to advancing precision care across imaging modalities and care pathways, including oncology, cardiology, and neurology. 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This marks the fourth consecutive year that GE HealthCare has topped the FDA's list of AI authorizations, underscoring its leadership and innovation in the field. The authorizations, obtained through various FDA pathways such as 510(k) clearances, De Novo requests, or premarket approvals, reflect GE HealthCare's commitment to advancing precision care across imaging modalities and care pathways, including oncology, cardiology, and neurology. This achievement highlights the company's ongoing investment in research and development, as well as its dedication to leveraging AI, cloud, and software to enhance patient outcomes and healthcare efficiency.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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